Supernus Pharmaceuticals plans to resubmit its application seeking approval of SPN-830, its apomorphine infusion pump for people with Parkinson’s disease, to the U.S. FDA by the end of this year, reports Parkinson’s News Today.
The decision comes after a meeting with the FDA last month at which the agency’s October decision not to approve the pump was discussed in greater detail, according to a Supernus press release. The FDA previously said more information was needed before it would reconsider an application.
Apomorphine (sold under the brand name Apokyn, among others) is a compound that mimics the action of dopamine in the brain to treat motor fluctuations, or off episodes, that occur between doses of dopamine-replacing therapies for some patients. Apomorphine often is administered as an on-demand, under-the-skin injection during off episodes.
SPN-830 instead uses an infusion pump device to continuously deliver apomorphine to patients, allowing for fewer injection sites and more convenient dosing. Originally developed by US WorldMeds, it was acquired by Supernus in 2020.
Supernus first sought approval for SPN-830 in December 2020, but the FDA requested additional information and supporting data, prompting the company to resubmit the application in December 2021. That resubmission was granted a standard review with an expected decision in October 2022, but the FDA again requested more information for the application related to issues with the therapy’s labeling, quality and manufacturing, and device performance. Still, no new clinical safety and efficacy data were requested.
Supernus’ requests for approval of SPN-830 have been based largely on data from two Phase 3 clinical trials. In both, results showed that the treatment led to significant reductions in daily off time after about three months which were generally sustained for the entire year of treatment.